Prevention of Nausea Associated With Motion SicknessPhase 3INSCOPNCT03920644
Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels
A Phase 3 study testing Scopolamine Transdermal Patch [Transderm Scop] and Scopolamine in people with Prevention of Nausea Associated With Motion Sickness and Treatment of Nausea Associated With Motion Sickness, run by Naval Aeromedical Research Unit, Dayton at 1 site in United States.
Trial summary
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Nausea Associated With Motion Sickness, Treatment of Nausea Associated With Motion Sickness
- What is being tested?
- Scopolamine Transdermal Patch [Transderm Scop] and Scopolamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2019to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Provision of signed and dated Informed consent document (ICD). 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
- 3. Male or female, aged 18 to 59 (inclusive). 4. Tricare health insurance beneficiary. All potential subjects must be able to provide a current military Identification (ID) or Department of Defense (DOD) dependent ID to be viewed by the research staff prior to signing the ICD.
- 5. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the MSSQ.
- 6. In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as assessed by the research staff.
- 7. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
- 8. For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test during the Screening Visit and each day of the Treatment Period. Test must be negative or the subject will be excluded from the study. Note: Women of non-childbearing potential are defined as those who are non-surgically sterile (i.e., without menses for at least 12 consecutive months) or surgically sterile (i.e., those who underwent a hysterectomy with or without oophorectomy, fallopian tube ligation, and endometrial ablation).
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- 9. Agreement to adhere to the following lifestyle compliance considerations:
- Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the Treatment Period.
- Abstain from alcohol for 24 hours prior to first dose of study medication and during the Treatment Period.
- Note: there will be no restriction on caffeine or nicotine use during the study; however, the actual use of these substances will be recorded as part of the CEBQ.
Who cannot join
- 1. Pregnancy, lactation, or positive urine pregnancy test at any time. 2. Known allergic reactions to any drugs. 3. Currently prescribed any of the following medication types: any form of scopolamine (including Transderm Scop®) within 5 days, belladonna alkaloids within 2 weeks, antihistamines (including meclizine) within 2 weeks, tricyclic antidepressants within 2 weeks (depending on reason taken), muscle relaxants and nasal decongestant within 4 days of Module 1.
- 4. Hospitalization or significant medical event (to include childbirth) within the past six months.
- 5. Treatment with another investigational drug or other intervention within the past 30 days.
- 6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
- 7. Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or Study Physician:
- Any known drug allergies and/or severe year-round environmental allergies.
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- Significant gastrointestinal disorder, asthma, or seizure disorders.
- History of vestibular disorders.
- History of narrow-angle glaucoma.
- History of urinary retention problems.
- History of alcohol or drug abuse.
- Nasal, nasal sinus, or nasal mucosa surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NAMRU Dayton
Dayton, Ohio, 45433
Joshua Baker, MS, 937-656-2473, Joshua.baker.16.ctr@uf.af.mil
Jackie Gomez, BS, 937-938-3923, jacqueline.gomez.3.ctr@us.af.mil
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Defender Pharmaceuticals Inc, (DPI)-386 Nasal Gel on Ocean-Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will be conducted aboard military ships undergoing military operations or aboard commercial boats rented for the study to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.
- Conditions
- Prevention of Nausea Associated With Motion Sickness, Treatment of Nausea Associated With Motion Sickness
- Being tested
- Scopolamine Transdermal Patch [Transderm Scop], Scopolamine, Placebo Patch, Placebo Gel
- Keywords
- Motion Sickness, INSCOP, Scopolamine, Defender, NAMRU
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scopolamine Transdermal Patch [Transderm Scop]Drug
Also called TDS, Patch
Current Motion Sickness treatment, 1 patch behind the ear.
ScopolamineDrug
Also called DPI-386
IND, up to 6 administration of intranasal gel.
Placebo PatchDrug
Placebo Patch, 1 patch behind the ear.
Placebo GelDrug
Placebo Gel,up to 6 administration of intranasal gel.
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | Receives Active Nasal Gel 2 times per treatment day Receives: Drug: Scopolamine; Drug: Placebo Patch |
| Placebo nasal gel | Placebo comparator | Receives Nasal Gel 2 times per treatment day Receives: Drug: Placebo Patch; Drug: Placebo Gel |
| TDS Patch | Active comparator | Receives one patch per treatment. Receives: Drug: Scopolamine Transdermal Patch [Transderm Scop]; Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of DPI-386 nasal gel compared to the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness.
The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ)(scale 1-10) scores over the treatment period across all three treatment arms
Measured: Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel compared to the TDS patch and placebo nasal gel with an emphasis on cognitive effects.
the safety endpoint is the incidence of adverse events.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.
Severity of nausea will measured by the Nausea Assessment (VAS)(scale 1-9) over the treatment period.
Measured: Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel as compared to the TDS patch and placebo nasal gel in terms of cognition.
Safety in terms of cognition will be measured by Computer task.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Nausea Associated With Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Aeromedical Research Unit, Dayton
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Matthew Doubrava, Naval Aeromedical Research Unit, Dayton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920644
- Sponsor's protocol ID
- NAMRUD.2018.0002 Field Trial
- Acronym
- INSCOP
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Defender Pharmaceuticals Inc, (DPI)-386 Nasal Gel on Ocean-Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness
- ClinicalTrials.gov ID
- NCT03920644
- Acronym / sponsor ID
- INSCOP / NAMRUD.2018.0002 Field Trial
- Conditions
- Prevention of Nausea Associated With Motion Sickness, Treatment of Nausea Associated With Motion Sickness
- Keywords
- Motion Sickness, INSCOP, Scopolamine, Defender, NAMRU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Naval Aeromedical Research Unit, DaytonUS federal agency
- Study start
- Apr 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will be conducted aboard military ships undergoing military operations or aboard commercial boats rented for the study to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.
| Arm | Type | Receives |
|---|---|---|
| DPI-386 Nasal Gel | Experimental | Drug: Scopolamine, Drug: Placebo PatchReceives Active Nasal Gel 2 times per treatment day |
| Placebo nasal gel | Placebo comparator | Drug: Placebo Patch, Drug: Placebo GelReceives Nasal Gel 2 times per treatment day |
| TDS Patch | Active comparator | Drug: Scopolamine Transdermal Patch [Transderm Scop], Drug: Placebo GelReceives one patch per treatment. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Provision of signed and dated Informed consent document (ICD). 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
- 3. Male or female, aged 18 to 59 (inclusive). 4. Tricare health insurance beneficiary. All potential subjects must be able to provide a current military Identification (ID) or Department of Defense (DOD) dependent ID to be viewed by the research staff prior to signing the ICD.
- 5. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the MSSQ.
- 6. In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as assessed by the research staff.
- 7. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
Key exclusion criteria (12 listed)
- 1. Pregnancy, lactation, or positive urine pregnancy test at any time. 2. Known allergic reactions to any drugs. 3. Currently prescribed any of the following medication types: any form of scopolamine (including Transderm Scop®) within 5 days, belladonna alkaloids within 2 weeks, antihistamines (including meclizine) within 2 weeks, tricyclic antidepressants within 2 weeks (depending on reason taken), muscle relaxants and nasal decongestant within 4 days of Module 1.
- 4. Hospitalization or significant medical event (to include childbirth) within the past six months.
- 5. Treatment with another investigational drug or other intervention within the past 30 days.
- 6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
- 7. Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or Study Physician:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scopolamine Transdermal Patch [Transderm Scop]Also: TDS, PatchCurrent Motion Sickness treatment, 1 patch behind the ear. | Drug | TDS Patch |
| ScopolamineAlso: DPI-386IND, up to 6 administration of intranasal gel. | Drug | DPI-386 Nasal Gel |
| Placebo PatchPlacebo Patch, 1 patch behind the ear. | Drug | DPI-386 Nasal Gel, Placebo nasal gel |
| Placebo GelPlacebo Gel,up to 6 administration of intranasal gel. | Drug | Placebo nasal gel, TDS Patch |
Primary outcome
Determine the efficacy of DPI-386 nasal gel compared to the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness.
Time frame: Through study completion, an average of 1 year
The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ)(scale 1-10) scores over the treatment period across all three treatment arms
Determine the safety of DPI-386 Nasal Gel compared to the TDS patch and placebo nasal gel with an emphasis on cognitive effects.
Time frame: Through study completion, an average of 1 year
the safety endpoint is the incidence of adverse events.
2 secondary outcomes
Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.
Time frame: Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel as compared to the TDS patch and placebo nasal gel in terms of cognition.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scopolamine Transdermal Patch [Transderm Scop] and Scopolamine in people with Prevention of Nausea Associated With Motion Sickness and Treatment of Nausea Associated With Motion Sickness, run by Naval Aeromedical Research Unit, Dayton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Baker, MS (9376562473, Joshua.baker.16.ctr@us.af.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of DPI-386 nasal gel compared to the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.